Guidance for Industry on Blue Bird Medicated Feed Labels; Availability, 19513-19514 [E8-7500]

Download as PDF Federal Register / Vol. 73, No. 70 / Thursday, April 10, 2008 / Notices used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 211.100, 211.160, and 211.165(e) have been approved under OMB Control No. 0910–0139; 21 CFR 312.23(a) and (b), 312.32(c), and Form FDA 1571 have been approved under OMB Control No. 0910–0014; and 21 CFR part 1271 has been approved under OMB Control No. 0910–0559. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. IV. Electronic Access mstockstill on PROD1PC66 with NOTICES Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/cber/guidelines.htm or https://www.regulations.gov. Dated: April 2, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–7588 Filed 4–9–08; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 16:48 Apr 09, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0165] (formerly Docket No. 2006D–0413) Guidance for Industry on Blue Bird Medicated Feed Labels; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (#181) entitled ‘‘Blue Bird Medicated Feed Labels.’’ This guidance provides new animal drug application (NADA) sponsors with the Center for Veterinary Medicine’s current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on this guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for Veterinary Medicine (HFV–220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453– 6856, e-mail: dragan.momcilovic@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of October 30, 2006 (71 FR 63328), FDA published a notice of availability for a draft guidance entitled ‘‘Draft Guidance for Industry: Blue Bird Medicated Feed Labels’’ giving interested persons until January 16, 2007, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. The guidance PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 19513 announced in this notice finalizes the draft guidance dated October 30, 2006. This Level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the agency’s current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 514.1(b)(3) have been approved under OMB control number 0910–0032. III. Comments Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments should be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/cvm or https:// www.regulations.gov. E:\FR\FM\10APN1.SGM 10APN1 19514 Federal Register / Vol. 73, No. 70 / Thursday, April 10, 2008 / Notices Dated: April 2, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–7500 Filed 4–9–08; 8:45 am] comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on ved several comments on the draft guidance and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated October 30, 2006. This Level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the agency’s current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/cvm or https:// www.regulations.gov. Dated: April 2, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–7500 Filed 4–9–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request mstockstill on PROD1PC66 with NOTICES II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 514.1(b)(3) have been approved under OMB control number 0910–0032. In compliance with the requirement for opportunity for public comment on dance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. III. Comments Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments should be identified with the docket number found in brackets in the heading of this document. Received SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),’’ dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human gene therapy. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. The guidance document announced in this notice finalizes the draft guidance of the same title dated November 2004. VerDate Aug<31>2005 16:48 Apr 09, 2008 Jkt 214001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: DATES: I. Background FDA is announcing the availability of a document entitled ‘‘Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),’’ dated April 2008. The guidance document provides to sponsors of a human gene therapy IND recommendations on the CMC information to include in an original IND. In addition, the guidance provides instructions to FDA reviewers about the information to record and assess as part of the IND review. This guidance will help sponsors and FDA reviewers to assess, given the phase of the investigation, whether sufficient information is provided to assure the proper identification, quality, purity, and potency of the investigational product. In the Federal Register of November 9, 2004 (69 FR 64958), FDA announced the availability of the draft guidance of the same title. FDA received several comments on the draft guidance and FDA considered those comments when finalizing the guidance. In addition, we revised the guidance to clarify its applicability for sponsors. The guidance announced in this notice finalizes the draft guidance dated November 2004. E:\FR\FM\10APN1.SGM 10APN1

Agencies

[Federal Register Volume 73, Number 70 (Thursday, April 10, 2008)]
[Notices]
[Pages 19513-19514]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7500]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0165] (formerly Docket No. 2006D-0413)


Guidance for Industry on Blue Bird Medicated Feed Labels; 
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry (181) entitled ``Blue 
Bird Medicated Feed Labels.'' This guidance provides new animal drug 
application (NADA) sponsors with the Center for Veterinary Medicine's 
current thinking on what constitutes recommended content and format of 
representative labels for new animal drugs intended for use in the 
manufacture of medicated feeds.

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your requests.
    Submit written comments on this guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for 
Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-453-6856, e-mail: 
dragan.momcilovic@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 30, 2006 (71 FR 63328), FDA 
published a notice of availability for a draft guidance entitled 
``Draft Guidance for Industry: Blue Bird Medicated Feed Labels'' giving 
interested persons until January 16, 2007, to comment on the draft 
guidance. FDA received several comments on the draft guidance and those 
comments were considered as the guidance was finalized. The guidance 
announced in this notice finalizes the draft guidance dated October 30, 
2006.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This guidance represents 
the agency's current thinking on the topic. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 514.1(b)(3) have been approved 
under OMB control number 0910-0032.

III. Comments

    Submit written requests for single copies of the guidance to the 
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and 
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one 
self-addressed adhesive label to assist that office in processing your 
requests.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/cvm or https://www.regulations.gov.


[[Page 19514]]


    Dated: April 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7500 Filed 4-9-08; 8:45 am]
BILLING CODE 4160-01-S

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